Chemistry, Pharmacology, and Quality Control of Selected Popular Asian Herbs in the U.S. Market

2005 ◽  
pp. 73-102
Author(s):  
Yi Jin ◽  
Chi-Tang Ho ◽  
Mingfu Wang ◽  
Qing-Li Wu ◽  
James Simon
Keyword(s):  
Quality Control ◽  
The U.S

scholarly journals Synthesis, quality control and dosimetry of the radiopharmaceutical 18F-sodium fluoride produced at the Center for Development of Nuclear Technology - CDTN

2010 ◽  
Vol 46 (3) ◽  
pp. 563-569 ◽  
Author(s):  
Marina Bicalho Silveira ◽  
Marcella Araugio Soares ◽  
Eduardo Sarmento Valente ◽  
Samira Soares Waquil ◽  
Andréa Vidal Ferreira ◽  
...  
Keyword(s):  
Quality Control ◽  
Sodium Fluoride ◽  
Radiochemical Purity ◽  
Nuclear Technology ◽  
Physical Chemical ◽  
Positron Emission ◽  
Oncological Diseases ◽  
Pet Scans ◽  
Quality Imaging ◽  
The U.S

18F-Sodium fluoride (Na18F) is a radiopharmaceutical used for diagnosis in nuclear medicine by positron emission tomography (PET) imaging. Bone scintigraphy is normally performed using 99mTc-MDP. However, 18F PET scans promise high quality imaging with increased resolution and improved sensitivity and specificity. In order to make available a tool for more specific studies of tumors and non-oncological diseases of bone tissue, the UPPR/CDTN team undertook the production and quality control of Na18F injectable solution with the physical-chemical, microbiological and biological characteristics recommended in the U.S. Pharmacopeia. Na18F radiochemical purity was 96.7 ± 1.3 %, with Rf= 0.026 ± 0.006. The product presented a pH of 5.3 ± 0.6, half life of 109.0 ± 0.8 minutes, endotoxin limit < 5.0 EU.mL-1 and no microbial contaminants. The biodistribution of Na18F was similar to that described in the literature, with a clearance of 0.19 mL.min-1 and distribution volume of 18.76 mL. The highest bone concentration (5.0 ± 0.5 %ID.g-1) was observed 20 minutes after injection. Na18F produced at the UPPR presented all the quality assurance requirements of the U.S. Pharmacopeia and can be safely used for clinical bone imaging.

scholarly journals Development of the Analytical Methods and Reference Materials Program for Dietary Supplements at The National Institutes of Health

2004 ◽  
Vol 87 (1) ◽  
pp. 162-165 ◽  
Author(s):  
Leila G Saldanha ◽  
Joseph M Betz ◽  
Paul M Coates
Keyword(s):  
Quality Control ◽  
Dietary Supplements ◽  
Reference Materials ◽  
Analytical Methods ◽  
Research Agenda ◽  
Control Unit ◽  
Lessons Learned ◽  
National Institutes Of Health ◽  
Good Manufacturing Practices ◽  
The U.S

Abstract The need for validated analytical methods and reference materials to identify and measure constituents in dietary supplements is essential. Such methods allow for the documentation that products meet manufacturer's specifications and contain what their labels declare. In March 2003, the U.S. Food and Drug Administration issued a proposed rule that would establish specific current good manufacturing practices for dietary supplements. This proposed rule requires that companies create a quality control unit to set specifications and ensure compliance with these specifications using scientifically valid procedures. This report provides insights and lessons learned from 3 meetings the Office of Dietary Supplements (ODS) at the National Institutes of Health helped organize. These meetings were structured to (1) educate individuals about the importance and need for validated analytical methods and reference materials to identify and quantify constituents of dietary supplements; (2) identify resources required to fulfill this need; and (3) serve as a platform to obtain input from interested parties to help frame the research agenda for the Dietary Supplements Methods and Reference Materials Program within ODS. Stakeholder's opinions and views expressed at these 3 meetings are outlined in this report.

Status and Near-Term Plans for the U.S. IOOS Quality Assurance / Quality Control of Real-time Oceanographic Data (QARTOD) Project

2018 ◽  
Author(s):  
Mark Bushnell ◽  
Robert Heitsenrether ◽  
Julie Thomas ◽  
Charlton Galvarino ◽  
Eugene Burger ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Real Time ◽  
Oceanographic Data ◽  
Near Term ◽  
The U.S

Quality Control of Real-Time Water Level Data: The U.S. IOOS® QARTOD Project

2018 ◽  
Vol 52 (2) ◽  
pp. 13-17
Author(s):  
Mark Bushnell
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Sea Level Rise ◽  
Water Level ◽  
Real Time ◽  
Sea Level ◽  
Hampton Roads ◽  
Level Data ◽  
Water Level Data ◽  
The U.S

AbstractWithin the U.S. Integrated Ocean Observing System Program, the Quality Assurance/Quality Control of Real-Time Oceanographic Data (QARTOD) Project develops manuals that describe variable-specific quality control (QC) tests for operational use. The QARTOD's Manual for Real-Time Quality Control of Water Level Data: A Guide to Quality Control and Quality Assurance for Water Level Observations was created with broad support from entities engaged in operational observations of water levels. The process used to generate this manual and all other QARTOD manuals exemplifies the integration of “federal, state, and local government agencies as well as the private and nonprofit sectors” described by the Hampton Roads Sea Level Rise Preparedness and Resilience Intergovernmental Pilot Project.Another project that supports Hampton Roads, Virginia, sea level rise and utilizes multiple partners is the deployment of continuous global positioning system (cGPS) receivers directly on water level sensors. These cGPS installations enable the determination of absolute sea level rise and local land subsidence. Successful transition of cGPS to an operational status requires the application of real-time data QC.

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